← FDA DRUG APPROVALS

FDA NDA · NDA021441

ADVIL ALLERGY SINUS

chlorpheniramine maleate, ibuprofen, pseudoephedrine hcl

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA021441
TYPE
NDA
ORIGINAL APPROVAL
2002-12-19
LATEST ACTION
2021-11-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

ADVIL ALLERGY SINUS · ReferenceOver-the-counter
CHLORPHENIRAMINE MALEATE 2MG, IBUPROFEN 200MG, PSEUDOEPHEDRINE HYDROCHLORIDE 30MG · TABLET · ORAL

Approval history

2021-11-23Labeling · Supplement 16 · standard — Letter ↗AP
2017-03-24Labeling · Supplement 12 · standard — Label ↗AP
2010-08-31Labeling · Supplement 11 · unknown — Letter ↗AP
2009-05-19Labeling · Supplement 9 · standard — Letter ↗AP
2008-06-23Labeling · Supplement 8 · standard — Letter ↗AP
2006-02-27Labeling · Supplement 5 · standard — Letter ↗AP
2004-07-09Labeling · Supplement 1 · standard — Label ↗AP
2002-12-19Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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